Over the week of September 17, 2007, Cephalon Inc., creator of cancer drug [Fentora]/companies/cephalon-inc/fentora.php, sent warning letters to doctors regarding several deaths linked to the drug.

[Fentora]/companies/cephalon-inc/fentora.php is a U.S. Food and Drug Administration (FDA) approved drug to treat acute cancer pain. Although [Fentora]/companies/cephalon-inc/fentora.php is approved by the FDA only to treat cancer patients, some physicians have prescribed the drug “off-label” for unapproved purposes such as headache and back pain relief.

According to Cephalon, [Fentora]/companies/cephalon-inc/fentora.php was linked to a total of four deaths. Cephalon reported that three deaths are the result of apparent [respiratory failure]. The fourth death was a man taking the drug who committed suicide.

Cephalon blamed the deaths on inappropriate prescription of the drug, but the FDA has not addressed fault in the situation. “We have been monitoring this issue. The FDA takes this very seriously, and we are working with the company to assure the safest possible use of this medication,” said FDA spokeswoman Susan Cruzan.

The Connecticut Attorney General began investigating Cephalon in 2004, when an allegation was raised against the company that it was marketing Fentora’s, off-label to doctors to treat headaches.

Cephalon has not released a comment regarding the investigation.

Source: “Cephalon Drug Is Tied to Several Deaths,” WSJ.Com, September 19, 2007.